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CARDIOVASCULAR
BACK
Abbott supports patients with advanced heart failure with mechanical pumps that restore blood flow to the body, both for the short- and long-term. We design our pumps to be gentle on the blood while they are working so that patients can live longer and fuller lives.
For a complete listing of potential adverse events please see the CentriMag System, HeartMate II or HeartMate 3 LVAD Adverse Events section listed below.
*PMA approval for 30-day use of CentriMag™ System components include: CentriMag™ Pump, CentriMag™ Console, CentriMag™ Motor, Mag Monitor, flow probe, and CentriMag™ Drainage Cannula and CentriMag™ Return Cannula. Optional accessories include: CentriMag™ System Cart, CentriMag™ System Transporter and Pressure Transducer. PMA approval for 30-day use of CentriMag™ System excludes: PediMag™ Blood Pump and any other pediatric components or accessories.
*Based on HeartMate 3™ LVAD highest published survival and lowest published stroke and thrombosis rates in a randomized controlled trial in the continuous-flow LVAD category of devices in the U.S.1,2-6
***HeartMate 3™ LVAD demonstrated superiority in event-free survival (primary endpoint) in the MOMENTUM 3 trial compared to HeartMate II™ LVAD.
Rx Only
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications [PMA Approval; 30-day use]: Temporary circulatory support for up to 30 days for one or both sides of the heart to treat post-cardiotomy patients who fail to wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient’s heart will recover or whether the patient will need alternative, longer-term therapy.
Contraindications [PMA Approval; 30-day use]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.
Adverse Events [PMA Approval; 30-day use]: Adverse events that may be associated with mechanical circulatory support can include, but are not limited to, the following: bleeding on device support, hemolysis, infection, renal failure/dysfunction/complication, respiratory dysfunction, hepatic dysfunction, cardia arrhythmias (atrial or ventricular), thromboembolism (venous and arterial non-CNS), hypotension, hypertension, device malfunction or failure, psychiatric events, right heart failure, and death.
Humanitarian Device Statement: Caution: Humanitarian Device. The CentriMag Circulatory Support System is authorized by Federal Law for temporary circulatory support for up to 30 days for patients in cardiogenic shock due to right ventricular failure. The effectiveness of this device for this use has not been demonstrated.
Indications [Humanitarian Exemption Device (HDE) Approval; 30-day use]: The CentriMag Circulatory Support System is intended to provide temporary circulatory support for up to 30 days for patients in cardiogenic shock due to acute right ventricular failure.
Contraindications [Humanitarian Exemption Device (HDE) Approval; 30-day use]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.
Temporary Expanded Indication: The FDA issued an enforcement policy guidance document in April 2020 allowing for FDA-cleared or approved cardiopulmonary bypass devices to be used in an ECMO circuit to treat patients who are experiencing acute respiratory failure and/or acute cardiopulmonary failure during the COVID-19 public health emergency. The CentriMag™ System including the CentriMag™ Blood Pump and PediMag™ Blood Pump are indicated for use as part of an ECMO circuit for longer than 6 hours to treat patients with acute respiratory failure and/or acute cardiopulmonary failure.
Indications [510(k) Clearance; 6-hour use]: The CentriMag Circulatory Support System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc.).
Contraindications [510(k) Clearance; 6-hour use]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.
Indications for Use [510(k) Clearance; 6-hour use]: The PediMag Blood Pump is indicated for use with the CentriMag Circulatory Support System console and motor to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours) for surgical procedures such as mitral valve reoperation. It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc.).
Contraindications [510(k) Clearance; 6-hour use]: The PediMag Blood Pump is contraindicated for use as a cardiotomy suction device. The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.
Rx Only
Brief Summary: Prior to using these devices, please review the Instructions For Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications: The HeartMate 3 Left Ventricular Assist System is indicated for providing short- and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in patients with advanced refractory left ventricular heart failure.
Indication: The HeartMate II Left Ventricular Assist System is indicated for use as a “bridge to transplantation” for cardiac transplant candidates who are at risk of imminent death from non-reversible left ventricular failure. It is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure, who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation. The HeartMate II™ Left Ventricular Assist System is intended for use both inside and outside of the hospital, or for transportation of Left Ventricular Assist Device patients via ground ambulance, airplane, or helicopter.
Contraindications: The HeartMate 3 and HeartMate II Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to anticoagulation therapy.
Adverse Events:Adverse events that may be associated with the use of the HeartMate 3 or HeartMate II Left Ventricular Assist System include, but are not limited to those listed below: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related), hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous system (CNS) thromboembolism, pericardial fluid collection, pump pocket or pseudo pump pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) and pump thrombosis.
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The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.
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